Effectiveness of Dental Caries Arrest Treatment in Primary Teeth Using AgNO3 Followed by NaF Varnish

Sponsor

The University of Hong Kong (Other)

Overall Status

Completed

CT.gov ID

NCT02019160

Collaborator

(none)

1,070

Enrollment

Location

Arms

Duration (Months)

23.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Aim: This randomised controlled trial will systematically compare the efficacy of a 25% AgNO3 solution followed by 5% NaF varnish with that of a 38% SDF solution in arresting caries teeth among preschool children when applied at half-yearly intervals over a 30-month period.
Method: The extension of the Consolidated Standards of Reporting Trials 2010 Statement will be followed for this 30-month, randomised, double-blinded, non-inferiority clinical trial. Approximately 2,400 kindergarten children will be screened and at least 826 children with caries will be recruited. This sample size is sufficient for an appropriate statistical analysis (power at 90% [β=0.10] with a 2-sided type-I error of α=0.05), allowing for a 18% drop-out rate. The children will be randomly allocated into 2 groups to treat their caries over a 30-month period: Group A - biannual application of a 25% AgNO3 solution followed by a 5% NaF varnish, and Group B - biannual application of a 38% SDF solution followed by a placebo varnish.Clinical examinations will be conducted at 6-month intervals to assess whether the caries are arrested. Information on confounding factors such as oral hygiene habits will be collected through a parental questionnaire.
Possible results and implications: As the first of its kind, this study would help to determine whether AgNO3 followed by NaF is at least as effective as SDF in arresting childhood caries. If so, because 25% AgNO3 and 5% NaF contain less silver and fluoride, respectively, than 38% SDF, their use would be more favourable than SDF in young children.

Condition or Disease	Intervention/Treatment	Phase
Early Childhood Caries	Drug: 25% AgNO3 solution followed by 5% NaF varnish Drug: 38% SDF solution followed by placebo varnish	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1070 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effectiveness of Biannual Application of Silver Nitrate Solution Followed by Sodium Fluoride Varnish in Arresting Early Childhood Caries in Preschool Children: a 30-month, Randomised, Double-blind, Non-inferiority Trial

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Jun 1, 2018

Actual Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Silver nitrate Biannual application of 25% AgNO3 solution followed by 5% NaF varnish.	Drug: 25% AgNO3 solution followed by 5% NaF varnish Dosage of 4.4μg±1.4μg fluoride per use Other Names: silver nitrate sodium fluoride
Active Comparator: Silver diamine fluoride Biannual application of 38% SDF solution followed by placebo varnish.	Drug: 38% SDF solution followed by placebo varnish Dosage of 8.8μg±2.8μg fluoride per use Other Names: silver diamine fluoride

Arm

Intervention/Treatment

Experimental: Silver nitrate

Biannual application of 25% AgNO3 solution followed by 5% NaF varnish.

Drug: 25% AgNO3 solution followed by 5% NaF varnish

Dosage of 4.4μg±1.4μg fluoride per use

Other Names:

silver nitrate

sodium fluoride

Active Comparator: Silver diamine fluoride

Biannual application of 38% SDF solution followed by placebo varnish.

Drug: 38% SDF solution followed by placebo varnish

Dosage of 8.8μg±2.8μg fluoride per use

Other Names:

silver diamine fluoride

Outcome Measures

Primary Outcome Measures

The hardness of cavity on tooth by probing [The follow-up oral examinations will be conducted every 6 months for 30 months totally]
We expect that topical application of 25% AgNO3 solution followed by 5% NaF varnish and of 38% SDF solution can both effectively arrest ECC.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Kindergarteners who have joined our outreach dental service will be invited to join this study. Preschool children aged 3-4 years who have tooth decay and are attending the first year of kindergarten will be invited to join this study.